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USER’S MANUAL

PRODUCT CO2 Surgical Laser System


MODEL MIXEL

VER 3.5 (01/13)


www.hironic.com

TABLE OF
CONTENT
TABLE OF
1. SYSTEM OVERVIEW 1.1. System Description>

1.2. System Componets and Features >


CONTENT 3
4
1.3. Symbol indication > 7

2. INSTALLATION 2.1. Prior to Installation > 9


2.2. How to Check the Main Body and Proper Installation > 9
2.3. Turn on/off > 11

3. OPERATION AND CAUTION 3.1. Description LCD > 12


3.2. Operation > 19
3.3. Notice > 24

4. GENERAL CARE AND STORAGE 4.1. Manage Notice > 26


4.2. Storage Precautions > 26
4.3. Preparation for Relocation > 27
4.4. Methods of Cleaning and Disinfecting > 27

5. MAINTENANCE AND
TROUBLESHOOTING 5.1. How to Deal with Emergency > 28
5.2. How to Deal with Problems > 29

6. GUARANTEE 6.1. Outline > 30


6.2. Gratuitous Guarantee > 30
6.3. Exceptional Cases from Gratuitous Guarantee > 30

VER 3.5 (01/13)


SYSTEM OVERVIEW INSTALLATION OPERATION AND GENERAL CARE AND MAINTENANCE AND GUARANTEE
CAUTION STORAGE TROUBLESHOOTING
PRODUCT OVERVIEW

1. SYSTEM OVERVIEW

1. 1. System Description
1.1.1. What is MIXEL?
Laser system MIXEL is composed of main body, handpiece, articulated arms, Foot switch, electrical accessories and

it is a carbon dioxide laser that uses fractional laser technology used as surgical tool for skin treatment requiring

cut or ablation.

1.1.2. MIXEL Specifications


1.1.2.1 Electrical Specifications
a) Medical Electrical Safety Standard : Shock Protected Class I equipment, Type B applied part

b) Laser Types and Laser Classification (IEC60825-1(2001)) : CO2 LASER, 4 Glass


c) Electrical Requirement : 22VAC ± 10%, 50/60Hz, 700VA

d) Laser Fractional Beam

● Material : CO2 LASER ● Laser Tube Type : All Metal sealed off RF CO2 Laser tube

● Laser Power : Max 15W ● Wavelength : 10.6um

● Spot Size : Max 20mm * 20mm ● Pulse Repetition Rate : 1Hz ~ 20Hz

● Device cooling : Air cooling

e) Laser Point Beam

● Material : Semoconductor Diode Laser ● Laser Type : CW Laser Diode

● Laser Power : Max 5mW ● Wavelength : 635nm

f ) Display : 10.4" Color LCD Touch Screen

g ) Protection

● Laser Output : Laser output does not occur when foot switch is pressed while it is not in ‘READY’ mode.

● Emergency Button : Stops generating laser immediately.

● Laser Over Current : Stops generating the laser if over-current flows more than 20% of rated voltage on laser diode.

● DSP Watchdog : Stops all the output if there are any abnormal operation in DSP or firmware.

● The protected circuit will start operating if over voltage current flows into circuit.

1.1.2.2. Mechanical Specifications


a) Dimension of Main Body[W X D X H] : 450mm X 480mm X 1870mm

b) Handpiece Size[W X D X H] : 70mm X 95mm X 205mm

c) Weight : Approx 48Kg

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CAUTION STORAGE TROUBLESHOOTING
PRODUCT OVERVIEW

1.2. System Components and Features


1.2.1. System Components
MIXEL system is consisted of the following items

Item Unit Remark


a MAIN BODY 1
b ARM 1
c SCANNER HANDPIECE 1
d FOOT SWITCH 1
e GOGGLES FOR PRACTITIONER 1
f GOOGLES FOR PATIENT 1
g POWER CABLE 1
h INTERLOCK 1
i REAR LOCK KEY 1
j KEY SWITCH 1

c. SCANNER HANDPIECE d. FOOT SWITCH

b. ARM

e. GOGGLES FOR
PRACTITIONER f. GOOGLES FOR PATIENT

a. MAIN BODY

g. POWER CABLE h. INTERLOCK

i. REAR LOCK KEY j. KEY SWITCH

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SYSTEM OVERVIEW INSTALLATION OPERATION AND GENERAL CARE AND MAINTENANCE AND GUARANTEE
CAUTION STORAGE TROUBLESHOOTING
PRODUCT OVERVIEW

1.2.2. System Components and Features


1.2.2.1. Main Body
[FRONT] [SIDE] [REAR]




③ ⑪




● Components and Description
NO Item DESCRIPTION (FUNCTION)
① Laser Output Arm Emits the energy generated from the body to the treatment area.
② Key Switch Power On / Off Key Switch
③ Emergency Button Stops the device immediately in an emergency situation.
④ LCD Control Panel This screen sets and displays the operation conditions.
⑤ Outlet for wind Product emits the heat through this outlet.
⑥ Interlock Switch It is a socket to connect Interlock switch.
⑦ Foot Switch Connector It is a socket to connect the foot switch.
⑧ Main Power Connector It is a socket to connect main power cord.

If you remove the sticker on the rear lock key and open it without
⑨ Rear Lock Key
permission from Hironic, you will be excluded from warranty. You can
⑩ Handle It is used when moving the product.
⑪ Handpiece Holder Hang the handpiece up on the holder

1.2.2.2. Handpiece

Item DESCRIPTION (FUNCTION)


A part where handpiece and articulated arm
① ARM JOINT
are connected.


② SCANNER Connection cable for scanner operation.
Aiming bar allows targeting correct area
③ AIMING BAR
while emitting laser.

④ LASER Shoots laser to treatment area.

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SYSTEM OVERVIEW INSTALLATION OPERATION AND GENERAL CARE AND MAINTENANCE AND GUARANTEE
CAUTION STORAGE TROUBLESHOOTING
PRODUCT OVERVIEW

1.3. Symbol indication

Symbol Definition

Dangers alert the user to information that is of the highest importance and vital to the
safety of the user and might cause severe damage to the device
[DANGER]

Warnings alert the user to information that is of importance and vital to the safety of
[WARNING] the user and might cause minor damage to the device

References alert the user to information that is vital and important to safely operate

[Reference] the device.

IEC417/878-02-02 Class B

Dangerous voltage
IEC417/878-03-01

Power Off
IEC417/5008

Power On
IEC417/5007

Earth Grounding
IEC417/5021

Keep electrical waste separate from municipal waste and ask to Hrionic to handle.
This mark is accordance with EU Waste Electrical and Electronic Equipment
Directive (Directive 2002/96/EC &EN50419)

Important matters while using

Reference clause related with corresponding clause in this manual

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SYSTEM OVERVIEW INSTALLATION OPERATION AND GENERAL CARE AND MAINTENANCE AND GUARANTEE
CAUTION STORAGE TROUBLESHOOTING
PRODUCT OVERVIEW

2. INSTALLATION

2.1. Prior to Installation


2.1.1. For the first time installation, please check the following :
● Consider the position and space of the device before installation.

● Keep at least 30cm of space from every side of the device

● Install the device at a maximum distance from other medical equipments generating high heat.

● Choose indoors that ventilation is available.


- In the acid air that has corrosiveness, it might cause corrosion to the electric cord and parts.
- Minimize the micro dusts flowing into the air. The micro dusts might flow into the electric parts and cause
severe damage to the device.

● The best safekeeping temperature of the device is 5~30℃ and the best usage temperature is 14~24℃.

● The relative humidity should be maintained at least between 0~80% range.

● Keep the power cable in clean and dry condition.

● Do not use a cable that has been damaged or is liquid fluid.

● Do not connect the device to multiple power socket with other devices. It might cause fire or explosion due to
abnormal heat.

● Use the power outlet having ground terminal. It might cause electrical effect leading to malfunction.

● Check if the foot switch cable is connected to the body socket.

[DANGER]
· In case of not following electrical requirements such as inappropriate usage or wrong voltage, the device
might be damaged or cause malfunction that could give fatal damages to human.

2.1.2. To relocate the device from the initial installation, please observe the following
● Disconnect cables prior to moving

● The handpiece should be firmly fixed to the holder to prevent falling down

● Put wheel breakers up in order to move

● Make a movement with grabbing the handle

● After relocating, put wheel breaks down to fix

● Connect the cables

[Warning]
· While moving, please do not give shock to the device

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SYSTEM OVERVIEW INSTALLATION OPERATION AND GENERAL CARE AND MAINTENANCE AND GUARANTEE
CAUTION STORAGE TROUBLESHOOTING
PRODUCT OVERVIEW

2.2. How to Check the Main Body and Proper Installation


● In case of the emergency situation during the operation, press the emergency stop switch located on the top
of main body to shut down the system. To restart, press the emergency stop switch or rotate it in a clockwise
direction. Ensure that the switch is protruded in proper position.

● Ensure that the power cord is connected to the socket properly. Do not handle the device with wet hands
because of the risk of electric shock.

● Key switch must be kept confidentially away from others to prevent using.

● Do not expose lamp light of the handpiece to reflective products [e.g. mirrors, jewelry and watches]. If the
lamp light is reflected and goes into the naked eyes, it might cause damage to the eyes.

● If the fuse is broken or the device do not power on because of overvoltage, exchange fuse on the lower rear
panel of the main body.

● If malfunction occurs during use, please contact customer service center of the local retailer immediately.
Only the authorized and trained personnel should check and fix the problem.

2.3. Turn on/off


● Connect the power cable into the wall power socket.

● Insert the key switch and turn the key clockwise to turn on.

● After warming up, check if the initial screen is displayed.

● When turning off, go to Standby mode and turn the key switch to counterclockwise direction to turn off.

● After relocating, put wheel breaks down to fix

[DANGER]
·It might cause malfunction if the power is turned OFF at Ready condition.
·When restarting the system, take at least 5 minutes after turning off the power for the stability of air cooling.

[Reference]
· The screen does not display any messages when key switch is turning OFF.
· If the power does not turn on when the power cable is properly connected to the socket, please check if
the emergency stop switch is pushed in. If it is pressed in, rotate it to clockwise direction and ensure that
the switch is protruded in proper position.

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SYSTEM OVERVIEW INSTALLATION OPERATION AND GENERAL CARE AND MAINTENANCE AND GUARANTEE
CAUTION STORAGE TROUBLESHOOTING
PRODUCT OVERVIEW

3. OPERATION AND CAUTION

3.1. Description LCD


The main function of each button is as follows.

① ⑩






⑮ 16 ⑪ ⑭
a) The main function of each button is as follows.
Class. Range Description
① POWER 1 ~ 60 mJ(1 step) Sets the laser energy
0.1 ~ 2.0 mm
② DENSITY Adjusts interval of dots.
(0.1 step)
Single – When foot S/W is pushed, the laser shoots once.
Single ~ 2.0 sec
③ REPEAT 0.5 ~ 2.0 – Continuously shoots the laser energy with regular interval with
(0.5 step)
pre-set value when pushing the foot switch.

④ OVER LAP 1 ~ 10 (1 step) Sets the number of laser emission per one each dot.
2*2 ~ 20*20 mm
⑤ SCAN FIELD Sets the size of laser emitting area
(1 step)

: Up or down both X and Y Size.


⑥ SIZE CONTROL
: Up or down only X or Y as selected.

⑦ SHAPE SQUARE, CIRCLE Selects the shape of laser emitting area ( Square or Circle )

Selects the laser emitting direction.


RIGHT, LEFT, (Right – shooting starts from the right.
⑧ PATTERN ODD, RANDOM, Left - shooting starts from the left.
SCATTER ODD – shooting every other line.
Random – shooting randomly in order.

⑨ DOTS Automatic Displays the total number of dots currently set.

Displays the automatically calculated proportion of current shooting size to


⑩ COVERAGE Automatic
the total laser beam size.

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CAUTION STORAGE TROUBLESHOOTING
PRODUCT OVERVIEW

Class. Range Description


STANDBY / Standby – Standby
⑪ Standby, Ready
READY Ready – Ready to operate guide beam

⑫ BACK Go back to ‘Mode Select’ screen.

⑬ SAVE Saves current setting parameters


⑭ MEMORY 1-6 Brings the saved values for each number.
⑮ SOUND ON, OFF Turn on or off button sound.
16 AIMING BEAM 1,2,3,4 Adjusts the brightness of Aiming Beam.

To increase or decrease values.

b) CO2 Mode

Class. Range Description


CONTINUE
① Select as to emit energy in continuous wave
WAVE

② PULSE Select as to emit energy in pulse

③ POWER 1 ~ 15 W (1 step) Sets the emitting power of CW Laser.

100~1,000us
④ ON TIME In Pulse laser mode, set the emitting time for one-time shooting.
(20 step)

1~10ms(1step)
10~100ms(10step)
⑤ OFF TIME In Pulse laser mode, set the standby time for the next shooting.
100~1,000ms
(100step)

STANDBY / Standby – Standby


⑥ Standby, Ready
READY Ready – Ready to operate guide beam

⑦ BACK Return to ‘Mode Select’ screen

⑧ To increase or decrease values.

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SYSTEM OVERVIEW INSTALLATION OPERATION AND GENERAL CARE AND MAINTENANCE AND GUARANTEE
CAUTION STORAGE TROUBLESHOOTING
PRODUCT OVERVIEW

3.2. Operation
For detailed operation method, please refer to the appendix Protocol.

3.3. Notice
3.3.1. Safety checks before use
● Update patient’s treatment record information prior to treatment.

● Based on a clinical treatment guideline and patient’s condition, set a proper parameter.

● Check the patient skin condition for the laser treatment. Hairs after shaving, any black substances, lotion,
perfumes, sun blocks, and local anesthetics should not be left.

● The device should always be kept in ‘Stand by’ mode if it is not operated.

● Confirm the existence of contaminants on the emitting area and remove it by using gauze and alcohol.

3.3.2. Precautions before use


● Patients with light sensitive skin or chronic skin disease should avoid treatment.

● Not for pregnant women and children.

● Not for patient with progressive dermatitis.

● Skin exposed to heavy sun should avoid treatment.

● Not allowed to use acne medicine and bleaching or retinol containing products from 1 day before treatment.

3.3.3. Precautions during use


● Practitioner and assistant should wear protective goggles.

● Patient should wear protective goggles during treatment.

● Control the entrance during operation, as laser is not seen through eyes and might give severe effect.

● As laser pointer emits very strong energy, do not emit when touching this area.

● Do not look at the laser pointer when laser emits in Ready mode.

● Be caution that long hairs can cause skin burn.

3.3.4. Precautions after use


● Avoid direct sunlight when going out.

● Must avoid hot bath and sauna.

● Do not sweat too much from exercise.

● During treatment period, it is recommended to use sunblock.

● If any problems occur on the skin, please see a doctor or dermatologist.

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SYSTEM OVERVIEW INSTALLATION OPERATION AND GENERAL CARE AND MAINTENANCE AND GUARANTEE
CAUTION STORAGE TROUBLESHOOTING
PRODUCT OVERVIEW

4. GENERAL CARE AND STORAGE

4.1. Manage Notice


● Do not fold or bend the connection hose linked to the handpiece and main body.
● Inspect the device and its components on a regular basis.
● Do not disassemble the device without Hironic permission. There are no components inside that user can
control and it might cause electric shock. In this case, user will take all responsibilities and will be excluded

from warranty condition.

● Keep the device in a dry condition.


● Keep the device in good environment conditions, away from sun exposure, severe humidity, strong wind, dust
and salt which might cause adverse affects.

● Avoid risk of shock, vibration and slope during storage.


● Disconnect the power cord and reseal it in a pouch for long period of storage.
● Before using the device that was not operating for long time, check the safety of operation prior to use.
● Avoid area that temperature might increase because of direct sunlight.
● Be careful not to drop the handpiece on the floor.

4.2. Storage Precautions


● Disconnect the power cord from the socket and store.
● The device is intended for indoor, dry location use.
● Keep the device in good environment conditions, away from sun exposure, severe humidity, strong wind, dust
and salt which might cause adverse affects.

● Avoid risk of shock, vibration and slope during storage.


● Do not keep in place where chemicals or gas is located.
● Inspect the device and its components on a regular basis.

[Danger] Suitable Condition for the Device Operation and Storage


· Temperature : 10℃~40℃(Operation), 5℃~40℃(Storage)

· Relative Humidity : Below 55%(Operation), 10~80%(Storage)

· Air Pressure : 500hpa~1060hpa

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SYSTEM OVERVIEW INSTALLATION OPERATION AND GENERAL CARE AND MAINTENANCE AND GUARANTEE
CAUTION STORAGE TROUBLESHOOTING
PRODUCT OVERVIEW

4.3. Preparation for Movement


When relocating the device within the treatment room or to far distance, please follow these instructions. Only

educated and trained person by Hironic may perform this relocation.

● Must disconnect the power cord prior to moving.


● Firmly fix the handpiece to the holder to prevent falling down.
● Put wheel breakers up in order to move.
● Make a slow movement by grabbing the handle.
● After relocating, put wheel breaks down to fix.
● Connect the power cord.
● Disassemble the main body, handpiece and power cable.
● Re-package the device with the original wrapping materials in a container which the device was initially
packaged and shipped.

● Please contact Hironic or local agency for safe delivery when you move the device to far distance.

4.4. Methods of Cleaning and Disinfecting


● After every treatment, it is recommended to remove any alien substances on handpiece or completely clean
with gauze, and finally clean using soft cotton soaked with alcohol.

● Use a soft cotton when you clean the LCD screen.


● When cleaning the surface of device, rub it with soft cotton that contains oil-free and moderate water.

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SYSTEM OVERVIEW INSTALLATION OPERATION AND GENERAL CARE AND MAINTENANCE AND GUARANTEE
CAUTION STORAGE TROUBLESHOOTING
PRODUCT OVERVIEW

5. MAINTENANCE AND TROUBLESHOOTING

5.1 How to Deal with Emergency

Problem Troubleshooting

· Turn off the power by pressing the emergency stop switch or turning off
the key switch
· Disconnect the power cord from the socket
When burning smell comes
· Contact a local agency or Hironic C/S center
out from the device
[Warning] If you use the device continuously, this might cause
damage to module inside that leads to high risk of fire and other
safety threats

· Turn off the power by pressing the emergency stop switch or turning off
the key switch
· Disconnect the power cord from the socket
When explosion sound comes
· Contact a local agency or Hironic C/S center
out from the device
[Warning] If you use the device continuously, this might cause
damage to module inside that leads to high risk of fire and other
safety threats.

∙ Stop operating the device immediately


∙ Turn off the power and disconnect the power cord from the socket
∙ Contact a local agency or Hironic C/S center
When the glass of LCD touch

screen is broken
[Warning] If you use the device continuously when the glass of LCD
touch screen is broken, emitting energy will be irregular causing
damage to skin.

∙ Check if there were relocation with the device recently.


When guide beam and output
∙ Minor vibration from the relocation might cause alignment tilt problem.
come out in different place
∙ Check if the arm and handpiece are connected properly.

∙ Check if there are any alien substances on scanner or lens on handpiece


When the output power of
∙ Soak a swab in alcohol and clean the laser point area.
beam is different

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SYSTEM OVERVIEW INSTALLATION OPERATION AND GENERAL CARE AND MAINTENANCE AND GUARANTEE
CAUTION STORAGE TROUBLESHOOTING
PRODUCT OVERVIEW

5.2 How to Deal with Problems

Problem Troubleshooting

∙ Check if the outlet is powered on and plug is inserted correctly


∙ Make sure that the product and power cord are fixed together
∙ Check the condition of Fuse that located below power cable connector
When the device is not and exchange just in case there are any problems
turned on ∙ If the emergency stop switch is pushed in, rotate it to clockwise direction
until it becomes protruded.
∙ If you could not solve the problem after trials of above clauses, please
contact a local agency or Hironic C/S center.

· When power does not turn OFF when manipulating Key switch during
product operation, push the emergency stop switch immediately to turn
OFF the power.
When power key switch does ∙ After disconnecting the power cord from the plug, rotate the key switch
not work left to right for 2-3 times and check the operating condition.
∙ Plug in the power cord and turn ON the power to check the operation.
∙ If the same situation occurs after repeating 2-3 times, please contact a
local agency or Hironic C/S center.

∙ In case of power turning off when handpiece emits a shot during use
Symptoms with lack of
∙ In case of touch screen operation error when handpiece emits a shot
power supply when using the
during use
product
∙ In case of often occurrence in fuse disconnection

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SYSTEM OVERVIEW INSTALLATION OPERATION AND GENERAL CARE AND MAINTENANCE AND GUARANTEE
CAUTION STORAGE TROUBLESHOOTING
PRODUCT OVERVIEW

6. GUARANTEE

6.1. Outline
The following explains about the gratuitous guarantee when operating device properly and limited guarantee
matters during the warranty period.

6.2. Gratuitous Guarantee


● When you use Mixel device properly and take after-service, Hironic gratuitously guarantees 14 months from the
date of invoice or for 12 months from installation date, whichever comes earlier, that its products are free from
defects in material and workmanship under normal use and service.
● Gratuitous guarantee includes a device body, a handpiece, a grounding pad and a foot switch except the
consumables.
● When the gratuitous guarantee is requested, we will promptly deal with it. Depending on the components to repair
or replace, it will be accomplished at the Hironic company or the designated place where the device is installed.
● When the device is needed to be collected for repair or control, Hironic will provide necessary information or
temporary device according to the customer’s request.
● When you request gratuitous guarantee, you should provide Hironic materials and videos to check the problem of
product.

[DANGER]
· For the gratuitous guarantee, any change or repair should be accomplished by an authorized
service person by Hironic. If the device is used by unintentional purpose or users do not
observe this manual, then users will be excluded from gratuitous guarantee.
· Hironic has the responsibility and rights to judge products’ troubleshooting and those causes.

6.3. Exceptional Cases from Guarantee


If you do not observe the operation procedure and the safety guideline presented this manual, you will not get the
gratuitously guaranteed repair. There are a few exceptional cases from gratuitous guarantee; you should pay more
attention to the following.

● When the handpiece connection parts got damaged due to hard pulling or twisting
● When the user opens, dismantles or changes the device without approval from Hironic. And when the user
use the device for unintentional purposes
● Consumables which maintain the device
● When the device is broken because of the user’s misuse or fault
- In case the handpiece is broken because it is dropped on the floor
- In case the handpiece is broken by excessive force at both ends of the hose where connected to the body
● When anyone who is non-certified service personnel decompose or repair the device arbitrarily
● When the seal sticker at rear panel is removed without the approval from Hironic.

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PRODUCT OVERVIEW

PRODUCT OVERVIEW

Letter of Guarantee

The seller does not have any responsibility for guaranteeing marketability or condition of the device. This letter of

guarantee replaces other explicit or tacit guarantee

Hospital Name

Contact Person

Address

Office Telephone

Cell Phone

Email

Device Name ● MIXEL

Serial NO. ● HMX

Installation Date ●

Guarantee ●
Expiration Date
Seller Name /
Company
Seller Telephone

Others

Important!
For the guarantee, please send above content to the following address by email or fax

Manufacturer : Hironic Co., Ltd.

9F Sicox Tower, Sangdaewon-dong, Joongwon-gu,

Sungnam-si, 462-120, Korea


Tel : +82-31-698-4900 Fax: +82-31-777-9713

Homepage : www.hironic.com E-mail : service@hironic.com

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PRODUCT OVERVIEW

PRODUCT OVERVIEW

MEMO

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USER MANUAL
Hironic Co., Ltd.
9F Sicox Tower, Sangdaewon-dong,
Joongwon-gu, Sungnam-si, 462-120, Korea

Tel : +82-31-698-4900

Fax: +82-31-777-9713

Homepage : www.hironic.com
E-mail : service@hironic.com

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